Clinical Development Lead/CDL or Sr. Clinical Scientist/CS

必須

• Knowledge, Skills & Experience

  • Japanese medical license (MD)
  • Clinical development experience in the pharmaceutical or vaccine industry (ideally 3–5+ years), or experience in clinical research.
  • Demonstrated experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders.
  • Proven ability to lead cross functional, matrixed teams and make high impact decisions.
  • Track record in clinical strategy development, study design, and benefit–risk assessment.
  • Strategic and scientific leadership with strong therapeutic/asset expertise.
  • Excellent stakeholder management, negotiation and influencing skills.
  • Strong problem solving, risk management and decision making capability.
  • Operational delivery focus with attention to quality and compliance.
  • Coaching and people development skills; ability to build high performing teams.
  • Familiarity with innovative clinical trial design and digital/remote approaches.
  • Fluent in Japanese and business level English (speaking and writing).
• 日本での就労資格を有すること。/ Legal right to work in Japan.

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Job Purpose

• The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical strategy, drives innovation and decision making, ensures compliance and quality, and leads cross functional teams to achieve timely, high quality development outcomes that deliver patient value. The CDL may also take responsibilities of Clinical Scientist (CS) when CS is not assigned.

Key Responsibilities

• Define and execute Japan clinical development strategy and local adaptations of global strategies, informed by deep asset/disease expertise, to deliver differentiated medicines/vaccines of value to patients, stakeholders and the market.
• Lead benefit–risk assessments and provide evidence based recommendations to central CDL, senior management and governance boards on PoS, go/no go decisions and risk mitigation.
• Provide matrix leadership across Japan clinical functions (Clinical Science, Clinical Operations, Medical Writing, Biostatistics, Data Management, etc.) to ensure integrated planning and robust execution oversight.
• Serve as the accountable decision maker to resolve disputes within the Japan clinical team and escalate where required.
• Act as a peer to central CDLs to align and optimize global clinical development strategy.
• Promote and implement innovative approaches (e.g., adaptive designs, digital endpoints, decentralised elements) to improve value, speed and efficiency.
• Represent Japan clinical development internally and externally
• Oversee clinical development activities to ensure quality and on time delivery.
• Coach and mentor CS and clinical colleagues to develop capability and a high performance team.
• Foster cross functional decision making, timely escalation and shared accountability.

Success measures / KPIs

• On time delivery of Japan clinical milestones (studies initiated, enrolment, submissions).
• Quality of regulatory interactions and acceptance of clinical part of Japan submissions.
• Alignment and integration of Japan clinical strategy with global strategy.
• Team capability growth and retention; successful mentoring of CSs and other team members.
• Demonstrated adoption of innovative approaches that improve timelines or value.
• Establishment of peer-to-peer relationship with a counter global CDL

Additional Information

• This role operates in a matrixed environment and will require close collaboration with global MDT/VDT and cross functional Japan teams.